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Non-invasive Brain Stimulation
Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions (RESTORE Trial)
N/A
Waitlist Available
Led By Ernest Pedapati, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how Theta Burst Stimulation (TBS), a non-invasive brain treatment using magnetic pulses, can help youth and young adults with Autism Spectrum Conditions who have severe depression that hasn't improved with other treatments. TBS aims to reset brain activity in areas that control mood, potentially reducing depression symptoms. TBS is known for its shorter and less intense sessions.
Eligible Conditions
- Autism Spectrum Disorder
- Autism
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change-from-baseline at 4 weeks in mean Hamilton Depression Rating Scale (HDRS-17) score.
Change-from-baseline at 4 weeks in mean and Beck Depression Inventory (BDI-II) scores.
Secondary study objectives
Change-from-baseline at 4 weeks in handgrip strength or relative handgrip strength.
Change-from-baseline at 4 weeks in physiological markers via the use of high-resolution electroencephalography (EEG).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BilateralExperimental Treatment1 Intervention
Theta burst stimulation (TBS)
Group II: UnilateralActive Control1 Intervention
Theta burst stimulation (TBS)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bilateral TMS
2021
N/A
~20
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,600 Total Patients Enrolled
26 Trials studying Autism Spectrum Disorder
10,900 Patients Enrolled for Autism Spectrum Disorder
Ernest Pedapati, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
40 Patients Enrolled for Autism Spectrum Disorder